Attachment A - SOW with Salient Characteristics-Specifications.docx

STATEMENT OF WORK (SOW)

RFQ: 36C26224Q1787

1. CONTRACT TITLE

Automated Electrophoresis Equipment

2. BACKGROUND

The VA Albuquerque Healthcare System Clinical Research Pharmacy Coordinating Center’s (CRPCC) Biorepository requires automated electrophoresis equipment to assess the integrity of various nucleic acid preparations.

3. SCOPE

This project requires the procurement of one (1) Brand Name or Equal Tape Station 4200 to include the necessary OEM installation and training requirements.

3.1 An automated electrophoresis system is a high-throughput system for use in DNA/RNA/Protein that allows for fast and efficient evaluation of sample quality. Automated electrophoresis systems provide several benefits over traditional gel electrophoresis. This includes (1) dramatically reduced sample and reagent consumption, (2) significantly faster analysis time (1-2 minutes per sample), (3) less hands on time, and (4) faster data analysis. By assessing sample quality, the biorepository can provide valuable information to investigators so they can decide if their samples can be used in downstream applications. These features make it an ideal solution for quality control of biological samples in next-generation sequencing, microarray, and qPCR workflows in high throughput applications. These systems offer walk-away operations with fully automated sample processing.

4. BRAND NAME ITEM DESCRIPTION

4200 TapeStation instrument includes a laptop PC, software, vortexer, accessories, plastic consumables, user information, and Installation and Familiarization. Does not include ScreenTape consumables and reagents; Tapestation 4200 B Series; D1000 ScreenTape, part of the TapeStation systems; D1000 Reagents containing Sample Buffer and Ladder< (>, <)> part of the TapeStation systems.

4.1 SALIENT PHYSICAL AND FUNCTIONAL CHARACTERISTICS

a) Flexibility to run any sample number at a constant cost per sample.

b) Small, efficient footprint (no bigger than 20x25 inches)

c) Nucleic acid analysis with reproducibility for size, concentration, and integrity. Can handle a wide variety of nucleic acid testing (RNA, DNA, cfDNA).

d) No risk of cross-contamination when loading multiple samples

e) Ability to purchase and use reliable integrity standards for RNA (RNA integrity number equivalent, RINe), genomic DNA (DNA integrity number, DIN), and cell-free DNA (%cfDNA)

f) Prepared samples can be placed in the instrument and analysis is started by a click of a button in the software. Consumables are ready-to-use and require no set up or priming or lengthy temperature equilibration periods.

g) System offers unattended walk away operation with fully automated sample processing for up to 96 samples with the automates loading, electrophoresis and imaging of the prepared samples, minimizing user intervention and delivering fast analysis.

h) Data analysis software is automatically launched with sizing, quantity and integrity information automatically presented depending on the application.

i) There is a constant cost per sample, and it is scalable from 1-96 samples run at one time.

j) Results are available in as little as 1-2 minutes per sample.

k) Requires only 1–2 μL of sample per run—even for high sensitivity analysis.

l) Ready to use consumables enable switching between DNA/RNA assays in no time.

m) System offers the unique numeric measurement – DNA integrity number (DIN) - for the assessment of input genomic DNA integrity from multiple sources including degraded genomic DNA samples isolated from Formalin Fixed Paraffin Embedded (FFPE) tissue.

n) Quality of cfDNA can be easily analyzed with a Cell-free DNA assay, which provides quantification and sizing information up to 800 bp as well as the detection of high molecular weight DNA contamination. The value % cfDNA provides an objective measure of cfDNA quality based on a preset region from 50 bp to 700 bp.

o) System utilizes individual loading tips for each sample. In addition, these tips are fitted with a barrier filter to prevent aerosol contamination of the pipetting mechanism.

p) Samples are analyzed in individual lanes on the device, integrating separate electrodes for each sample to avoid any cross-contamination.

q) Available assays that measure samples as low as 10-1000pg/μL and multiple assays kits allowing for the identification of fragments between 35-60000bp

r) System is no more than 60lbs.

s) System is delivered with standalone laptop with analytical software provided.

t) OEM Installation and training included.

u) GLP/GMP compliance to include audit-ready documentation and installation qualification (IQ) and operational qualification (OQ) service.

v) Capable of operating at altitudes 5300-5500 feet above sea level.

w) Power requirements: 120V (50-60Hz)

x) Sound Pressure <70 dB

5. PLACE OF PERFORMANCE

Equipment to be shipped to/installed at:

VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center 2401 Centre Avenue, SE ATTN: CSP Warehouse (151-I) Albuquerque, NM 87106-4180

6. PERIOD OF PERFORMANCE

Deliver all items including any installation and training requirements within 60 days of the Award Effective date.

(END OF SOW)